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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004985-74 | EudraCT Number |
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This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2, to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery outcome by prevention of excessive scarring and trabecular meshwork transformation.
The transforming growth factor beta (TGF-β) is known to play a key role in glaucoma. Increased levels of TGF-β2 in the eye have been linked to trabecular meshwork transformation, increased intraocular pressure and direct optic nerve damage.
Trabeculectomy is the standard surgical intervention to reduce intraocular pressure in subjects no longer sufficiently responding to pressure-lowering medications. Scarring of the surgically opened canal (bleb) often abolishes the effect of trabeculectomy (despite the intraoperative use of Mitomycin C to prevent this). TGF-β2 has been described to play a distinct role in the fibrotic process of bleb closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TGF-β2 antisense oligonucleotide | Experimental | Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses Post-Study Follow-up: until 1 year after administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGF-β2 antisense oligonucleotide | Drug | intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | 1 year | |
| Number of interventions post trabeculectomy | 1 year | |
| Visual field |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petra Fettes, PhD | Isarna Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Magdeburg, Ophthalmology | Magdeburg | 39120 | Germany | |||
| Department of Ophthalmology, Johannes-Gutenberg University Mainz |
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| Trabeculectomy | Procedure | Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control |
|
| 1 year |
| Mainz |
| 55131 |
| Germany |
| University of Tuebingen, Center of Ophthalmology | Tübingen | 72076 | Germany |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000625771 | ISTH0036 |
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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